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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent
510(k) Number K923679
Device Name ENDOPATH TISSUE RETAINING COMPONENT
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact MELISSA WALKER
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact MELISSA WALKER
Regulation Number874.5220
Classification Product Code
KCJ  
Date Received07/22/1992
Decision Date 09/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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